Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 085208
Company: ACTAVIS ELIZABETH
Company: ACTAVIS ELIZABETH
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 50MG | TABLET;ORAL | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 08/20/1981 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/20/2020 | SUPPL-39 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/23/2002 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/17/2002 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/02/2001 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/21/2001 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/13/1999 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 01/18/1996 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/02/1995 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 08/13/1993 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 01/28/1993 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 06/19/1992 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 08/12/1991 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/04/1990 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 11/14/1988 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 05/23/1988 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 06/17/1988 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/21/1987 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/13/1985 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/24/1982 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |